Studio di Retinfanlimab in combinazione con INCAGN02385 e INCAGN02390 come trattamento di prima linea in partecipanti con carcinoma a cellule squamose ricorrente/metastatico della testa e del collo positivo per PD-L1 (CPS ≥ 1)
Uno studio randomizzato, in doppio cieco, multicentrico, di fase 2 su Retifanlimab in combinazione con INCAGN02385 (Anti-LAG-3) e INCAGN02390 (Anti-TIM-3) come trattamento di prima linea in partecipanti con PD-L1-positivo (CPS ≥ 1) Carcinoma a cellule squamose ricorrente/metastatico della testa e del collo
The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Fase 2
Accesso esteso
Accesso esteso
A disposizione
- Disponibile: l'accesso esteso è attualmente disponibile per questo trattamento sperimentale e i pazienti che non partecipano allo studio clinico potrebbero essere in grado di accedere al farmaco, al biologico o al dispositivo medico in fase di studio.
- Non più disponibile: l'accesso esteso era disponibile per questo intervento in precedenza, ma non è attualmente disponibile e non sarà disponibile in futuro.
- Temporaneamente non disponibile: l'accesso esteso non è attualmente disponibile per questo intervento, ma dovrebbe esserlo in futuro.
- Approvato per il marketing: l'intervento è stato approvato dalla Food and Drug Administration degli Stati Uniti per l'uso da parte del pubblico.
Contatti e Sedi
Luoghi di studio
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Charleroi, Belgio, 06000
- Grand Hospital de Charleroi
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Hasselt, Belgio, 03500
- Jessa Ziekenhuis
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Wilrijk, Belgio, 02610
- Gza Sint Augustinus
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- McGill University Jewish General Hospital
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Montreal, Quebec, Canada, H2X 3E4
- McGill University Health Centre/Glen Site/Cedars Cancer Centre
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Montreal, Quebec, Canada, H2X3E4
- Chum Hospital Notre Dame
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Busan, Corea del Sud, 49241
- Pusan National University Yangsan Hospital
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Gwangju, Corea del Sud, 58128
- Chonnam National University Hwasun Hospital
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Seongnam-si, Corea del Sud, 13496
- Cha Bundang Medical Center
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Seoul, Corea del Sud, 05505
- Asan Medical Center
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Seoul, Corea del Sud, 03181
- Kangbuk Samsung Hospital
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Seoul, Corea del Sud, 02841
- Korea University Anam Hospital
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Seoul, Corea del Sud, 05030
- Kunkuk University Medical Center
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Yangsan, Corea del Sud, 50612
- Pusan National University Yangsan Hospital
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Bordeaux, Francia, 33000
- Centre Hospitalier Universitaire de Bordeaux
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Paris, Francia, 75248
- Institut Curie
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Rennes, Francia, 35042
- Centre Eugene Marquis
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Saint-Herblain, Francia, 44805
- Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
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Strasbourg, Francia, 67200
- Icans - Institut de Cancerologie Strasbourg Europe
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K'ut'aisi, Georgia, 04600
- Jsc Evex Hospitals
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Tbilisi, Georgia, 00114
- New Hospitals
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Tbilisi, Georgia, 00159
- Jsc Evex Corporation-Caraps Medline
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Tbilisi, Georgia, 0159
- Ltd Cancer Research Centre
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Cologne, Germania, 50937
- University of Cologne
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Hamburg, Germania, 22763
- Asklepios Klinik Altona
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Hamburg, Germania, 20246
- Universitatsklinikum Hamburg Eppendorf
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Mainz, Germania, 55131
- Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
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Chaïdári, Grecia, 12462
- University Hospital of West Attica - Attikon
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Thessaloniki, Grecia, 54007
- Theagenio Anticancer Hospital
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Thessaloniki, Grecia, 54622
- Bioclinic Thessaloniki (Galinos Clinic)
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Thessaloniki, Grecia, 55236
- Saint Lukas Clinic
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Candiolo, Italia, 10060
- Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
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Milan, Italia, 20133
- Fondazione Irccs Istituto Nazionale Del Tumori Di Milano
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Milan, Italia, 20141
- European Institute of Oncology
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Naples, Italia, 80131
- Istituto Nazionale Tumori Irccs Fondazione Pascale
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Padova, Italia, 35128
- Iov - Istituto Oncologico Veneto Irccs
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Pavia, Italia, 27100
- Fondazione Irccs Policlinico San Matteo
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Reggio Emilia, Italia, 42123
- Ausl-Irccs Di Reggio Emilia
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Amsterdam, Olanda, 1066 CX
- The Dutch Cancer Institue
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Leiden, Olanda, 02333
- Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center)
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Bydgoszcz, Polonia, 85-796
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka
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Konin, Polonia, 62-500
- Przychodnia Lekarska Komed Roman Karaszewski
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Lublin, Polonia, 20-090
- Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli
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Poznan, Polonia, 60-780
- Poznan University of Medical Sciences
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Tomaszów Mazowiecki, Polonia, 97-200
- Nzoz Provita Prolife Centrum Medyczne
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Warsaw, Polonia, 02-781
- Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
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Braga, Portogallo, 4710-243
- Hospital de Braga
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Faro, Portogallo, 8000-386
- Centro Hospitalar Universitario Algarve
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Lisbon, Portogallo, 1649-035
- Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria
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Porto, Portogallo, 4200-319
- Centro Hospitalar de Sao Joao Alameda
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Porto, Portogallo, 4200-072
- Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E.
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Vila Nova de Gaia, Portogallo, 4434-502
- Centro Hospitalar de Vila Nova de Gaia/Espinho, Epe-Unidade L
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Barcelona, Spagna, 08916
- Catalans Institute of Oncology Barcelona
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Girona, Spagna, 17007
- Ico Girona Hospital Universitari de Girona Dr Josep Trueta
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Madrid, Spagna, 28223
- Hospital Universitario Quironsalud Madrid
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Madrid, Spagna, 00034
- Fundacion Jimenez Diaz University Hospital
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Madrid, Spagna, 28036
- Hospital Universitario Ramon Y Cajal
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Málaga, Spagna, 29010
- Hospital Regional Universitario Carlos Haya
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Pamplona, Spagna, 31008
- Complejo Hospitalario de Navarra
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Santander, Spagna, 39008
- Hospital Universitario Marques de Valdecilla
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Valencia, Spagna, 46014
- Hospital General Universitario de Valencia
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Valencia, Spagna, 46026
- Hospital Universitari I Politecnic La Fe
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Arizona
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Scottsdale, Arizona, Stati Uniti, 85259
- Mayo Clinic Rochester
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California
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Duarte, California, Stati Uniti, 91010-9200
- City of Hope National Medical Center
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Irvine, California, Stati Uniti, 92618
- City of Hope Orange County
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La Jolla, California, Stati Uniti, 92093
- University of California San Diego Medical Center, Moores Cancer Center
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Lancaster, California, Stati Uniti, 93534
- City of Hope-Antelope Valley
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Long Beach, California, Stati Uniti, 90813
- City of Hope National Medical Center
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Long Beach, California, Stati Uniti, 90805
- Innovative Clinical Research Institute
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San Francisco, California, Stati Uniti, 94115
- University of California San Francisco Comprehensive Cancer Center
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District of Columbia
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Washington D.C., District of Columbia, Stati Uniti, 20057
- Georgetown University
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Florida
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Jacksonville, Florida, Stati Uniti, 32224
- Mayo Clinic Jacksonville
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Miami, Florida, Stati Uniti, 33174
- Blessed Health Care
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Tampa, Florida, Stati Uniti, 33612-9416
- Moffitt Cancer Center
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Illinois
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Chicago, Illinois, Stati Uniti, 60612
- University of Illinois At Chicago
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Iowa
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Iowa City, Iowa, Stati Uniti, 52242-1316
- University of Iowa
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Kansas
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Kansas City, Kansas, Stati Uniti, 66103
- University of Kansas Hospital Authority
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Maryland
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Baltimore, Maryland, Stati Uniti, 21201
- University of Maryland-Greenebaum Cancer Center
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215
- Dana Farber Cancer Institute
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- University of Michigan Cancer Center
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Detroit, Michigan, Stati Uniti, 48201
- Barbara Ann Karmanos Cancer Hospital
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New Jersey
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Hackensack, New Jersey, Stati Uniti, 07601
- Hackensack University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19111
- Fox Chase Cancer Center
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Utah
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Salt Lake City, Utah, Stati Uniti, 84112
- Huntsman Cancer Institute At University of Utah
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Virginia
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Charlottesville, Virginia, Stati Uniti, 22903
- University of Virginia - Emily Couric Clinical Cancer Center
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Washington
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Kennewick, Washington, Stati Uniti, 99336
- Kadlec Clinic Hematology and Oncology
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Kaohsiung City, Taiwan, 80708
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung City, Taiwan, 83301
- Chang Gung Medical Foundation. Kaohsiung Branch
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Taichung, Taiwan, 00112
- China Medical University Hospital
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Taipei, Taiwan, 00112
- Institutional Review Board Taipei Veterans General Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Histologically or cytologically confirmed R/M SCCHN that is not amenable to therapy with curative intent. Participants who refuse potentially curative salvage surgery for recurrent disease are ineligible.
- Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
- Participants must not have received prior systemic therapy for R/M SCCHN.
- PD-L1 positive tumor status defined by CPS ≥ 1% per central laboratory determination.
- For participants with primary oropharyngeal tumors, documentation of HPV p16 status based on local institutional standard is required. HPV p16 status is not required for other eligible SCCHN primary tumor sites.
- Participant must have at least 1 measurable tumor lesion per RECIST v1.1.
- Availability of archival tissue for biomarker analysis from a core or excisional biopsy or willingness to undergo a fresh biopsy.
- ECOG performance status of 0 or 1.
- Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
- Progressive or recurrent disease within 6 months of the last dose of systemic treatment for locally advanced SCCHN. Prior PD-(L)1, LAG-3, or TIM-3 directed therapy, or any other checkpoint inhibitor therapy, for SCCHN or any other malignancy.
- Treatment with anticancer therapies or participation in another interventional clinical study within 21 days before the first administration of study treatment.
- Presence of tumors that invade major blood vessels, as shown unequivocally by imaging, and with active bleeding.
- Participants with primary tumors of the nasopharynx, sinonasal cavity, or salivary and are excluded.
- Less than 3-month life expectancy.
- Participant has not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy.
- Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study treatment.
- Palliative radiation therapy administered within 1 week before the first dose of study treatment or radiation therapy in the thoracic region that is > 30 Gy within 6 months before the first dose of study treatment.
- Known active CNS metastases and/or carcinomatous meningitis. Participants will be excluded if it has been < 4 weeks since radiation therapy was delivered to the CNS.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: Treatment Group 1: Retifanlimab Monotherapy
Retifanlimab will be administered intravenously every 4 weeks. Placebos for INCAGN02385 and INCAGN02390 will be administered intravenously every 2 weeks. |
Retifanlimab 500mg will be administered intravenously every 4 weeks. Placebo will be administered intravenously. |
|
Sperimentale: Treatment Group 2: Retifanlimab + INCAGN02385
Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks. |
Retifanlimab 500mg will be administered intravenously every 4 weeks. Placebo will be administered intravenously. INCAGN02385 350mg will be administered intravenously every 2 weeks. |
|
Sperimentale: Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390
Retifanlimab plus INCAGN02385 and INCAGN02390 will be administered intravenously. Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and INCAGN02390 will be administered every 2 weeks. |
Retifanlimab 500mg will be administered intravenously every 4 weeks. INCAGN02385 350mg will be administered intravenously every 2 weeks. INCAGN02390 400 mg will be administered intravenously every 2 weeks. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progeression-free Survival (PFS)
Lasso di tempo: up to 738 days
|
PFS was defined as the time from the date of randomization to the date of the first documented progression, as determined by investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death due to any cause, whichever occurred first. |
up to 738 days
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Objective Response
Lasso di tempo: up to approximately 44 months
|
Objective response was defined as having a complete response (CR) or partial response (PR), determined based on investigator assessment per RECIST v1.1, recorded post-baseline before and including the first progressive disease, and before new anticancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. |
up to approximately 44 months
|
|
Duration of Response (DOR)
Lasso di tempo: up to approximately 44 months
|
DOR was defined as the time from earliest date of disease response (CR or PR) until the earliest date of disease progression, based on investigator assessment per RECIST v1.1, or death from any cause if occurring sooner than progression. |
up to approximately 44 months
|
|
Disease Control
Lasso di tempo: up to approximately 44 months
|
Disease control was defined as having CR, PR, or stable disease (SD) as best response on or after Day 180, based on investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. |
up to approximately 44 months
|
|
Overall Survival
Lasso di tempo: up to approximately 44 months
|
Overall survival was defined as the time from the date of randomization to the date of death due to any cause. |
up to approximately 44 months
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Lasso di tempo: up to approximately 44 months
|
Adverse events (AEs) were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 90 days of the last administration of study drug. |
up to approximately 44 months
|
|
Number of Participants With TEAEs Leading to Treatment Interruption, Dose Delay, and Withdrawal of Study Treatment
Lasso di tempo: up to approximately 44 months
|
AEs were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 90 days of the last administration of study drug. |
up to approximately 44 months
|
Collaboratori e investigatori
Sponsor
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- INCAGN 2385-203
- 2021-005775-39 (Numero EudraCT)
- 2023-504270-38-00 (Identificatore di registro: EU CT Number)
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Periodo di condivisione IPD
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Criteri di accesso alla condivisione IPD
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .